JOHN DWYER. The parlous state of strategies to protect consumers from health care fraud. Part 1 of 3

Credible scientific evidence of clinical effectiveness should underpin the delivery of health care. Satisfactory health outcomes and cost effectiveness require this approach. In Australia however pseudoscience flourishes as regulatory bodies fail to protect consumers from health care fraud and a massive industry prospers as it convinces consumers to use expensive supplements they do not need. In this three part examination of the issue the extent of the problem is examined, as are the changes that would better protect consumers.

We live in the most scientific of all ages. Good scientists know that good science requires a total commitment to the unbiased gathering of evidence that is reproducible and supported by vigorous peer review. In such an age one would anticipate that credible scientific evidence of effectiveness would underpin the delivery of health care in our country. In truth however, pseudoscience is flourishing in many areas of health care.

Some of the concepts involved arose in pre-scientific times (much of Chinese Medicine) while more recent concepts represent anti-science in that our modern knowledge of chemistry, physics, anatomy and physiology makes a nonsense of the claims made by Homeopaths, Iridologists, healing touch therapists etc. We are living in a world however where “Fake News” and “Alternative Facts” flourish, and while we most often hear about this in a political context, the distortions can certainly be applied to our problem with contemporary health care fraud.

Another phenomenon that is certainly not justified by scientific investigation, involves the massive and very successful marketing of vitamins and health “supplements” to Australians. We spend over 3.9 billion dollars a year as we fall for this marketing which is more than our out of pocket expenditure on prescription drugs. We are urged to take supplements on a daily basis; ” have you had your inner health (probiotic) today?” asks our television. If you watched any of the recent Australian Open tennis matches on TV you will have noticed the saturation advertising from Blackmores telling you that you need to take a range of vitamins and supplements to be a “well-being”. Much of the marketing suggests that you can neutralise an unhealthy life style with things from a bottle. This is, in fact, a world- wide issue despite billions spent on research telling us that there is neither need nor advantage for the vast majority of us in taking these preparations. Marketing strategies rely heavily on celebrity endorsement (as if they have the expertise to be a credible messenger?) and company representatives “chatting” with radio announcers who agree with all that is said and in so doing use their credibility with listeners to endorse the claims made. In one memorable encounter a representative from “Nature B” discussed what a good idea it was to load up on Vitamin B tablets before going out on the town for a night of boozing!

Equally disturbing are the fraudulent advertisements that invade our TV screens and the magazines we read. Common examples involve weight reduction promises (“no diet, no exercise needed with our—“) and cures for impotence. Regrettably more than a few doctors are involved in these schemes and such nonsense as “chelation” therapy, claimed to help with a myriad of conditions when the only indication is heavy metal poisoning and intravenous vitamins infusions (especially Vitamin C) for everything from hangovers to stress reduction.

Proponents of the benefits of supplements etc, often quote a study that supports their contention but analysis all too often reveal, bias (the study is funded by a proponent who would gain financially from a positive result), poor methodology and gross exaggeration. In the news this week has been a story of a dramatic breakthrough in the treatment of children with attention deficit problems. “A Current Affair” featured the story that discussed research that used fish oil supplements to treat children with the problem. Highlighted throughout the story were photos of a Blackmores’ fish oil product. A pharmaceutical company funded the research. The scientific community rapidly noted problems with the study and “Media Watch” did a good job of pointing out that the results with the supplement where no better than those with a placebo as the author tried to distance himself from the exaggerated claims in the ACA story. Studies show that in 80% of fish oil products the potentially beneficial fatty acids they contain are oxidised and therefore useless. This is why experts want consumers to understand that eating fish is the only reliable way to get quality fish oil. There was no consumer protection in evidence here and many parents of children with Attention Defect problems where presented with false hope.

Consumer protection, such as it is relies on the regulations imposed by our Therapeutic Goods Administration (TGA) and its vigilance in assessing compliance, a National Law that forbids advertising of claims that are not evidence based, point of sale advice which for most of us should be supplied by our local pharmacist and the health literacy of the consumer.

Our pharmacists are caught up in a major conflict of interest that challenges their professionalism. Pharmacists are trained to appreciate and champion the importance of evidence based therapeutics. Their self-generated professional standards require them to adhere to this principle. However they make more money from selling so called “Alternative and Complementary” products than they do from filling your prescriptions. The majority of pharmacies now stock the front of their shops with supplements and the like with prescription services banished to a back corner. Many suppliers of vitamins and supplements have strict demands on display requirements and will only supply product if the full range is offered. Statements such as “as traditionally used” cover claims for efficacy. Pharmacist are well trusted by the public and wish to play a greater role in our Primary Care system but all too often are, in fact, compromising evidence based health care as commercial interests dominate their professional life.

As was reported on 4 Corners recently a Choice magazine undercover investigation, in which shoppers asked pharmacists to recommend something for stress, where offered alternative products for which there was no evidence to support claims of benefit and 26% of customers where offered nonsense products such as homeopathic preparations and Bach flower extracts! Out for consultation at the moment is a proposal from the TGA to introduce a distinctive label for non-prescription products whose claims are supported by credible scientific evidence. It is not clear how this would be achieved but it is an idea well worth pursuing. Manufacturers of all goods making therapeutic claims are required to have the evidence that supports their claims ready for inspection. The TGA has a random testing program whereby manufacturers are asked to produce that evidence and in about 80% of such inspections there is no such evidence available. There are many problems with the TGA’s approach to consumer protection that will be examined in part two of this contribution.

Professor John Dwyer is Emeritus Professor of Medicine UNSW, Foundation President of “Friends of Science in Medicine”.

5 Responses to JOHN DWYER. The parlous state of strategies to protect consumers from health care fraud. Part 1 of 3

Good science does not hold that “if it hasn’t been studied yet “it”cannot be efficacious”. If “it” hasn’t been studied we certainly don’t know if it is efficacious but if anecdotal observation suggest that “it” might be efficacious then scientific methodology can be used to answer the question. Much of our modern arsenal of valuable drugs have come from this approach.

There are many individuals who need targeted supplementation of their diets. Malnutrition among our elderly is common, pregnant women need folate etc. but decisions about supplementation should be individualised. The suggestion that everyone needs to take supplements to be a “well being” is wrong.

Of course the importance of all health professionals striving to have the care they offer evidence based should be a given. A rough but credible suggestion argues that the elimination of many unnecessary procedures and practices by medical doctors could save us 10 billion dollars a year.

Your piece is very well linked to the currency of ‘fake news’ and ‘alternative facts’; to which we might add ‘climate science denial’. It seems that people select the ‘facts’ about what they want to believe rather than seeking out reasoned evidence.

It will be interesting to see what you have to say about the Therapeutic Goods Administration.

It is scandalous that so much of public medical and health funding and subsidies are wasted on ‘fake cures’ while those with serious health needs experience barriers in accessing basic evidence-based health care.

I purchase quite a few vitamin supplements, but always do the research first. I subscribe to Consumer Labs, a consumer funded and independent US laboratory, which provides all the data and studies for and against various supplements as well as their own analysis of the different brands. Any brand which either exceeds or doesn’t have enough of the particular ingredient or compound, or has any contamination, is marked as – Do not buy. Prices are compared as well. (It is quite clear that they do not favour any particular brands.)
Recently, for example, I decided that I will no longer purchase (high priced) Himalayan or Celtic salt anymore as their analysis was that all these specialty salts provide insignificant amounts of minerals and trace elements.
I also check out various studies and abstracts on Pub Med, and have been able to reduce my LDL cholesterol by using a ‘natural’ statin – Red Yeast Rice – again using Consumer Labs to help find me a quality product.
I’m sure that there is much money wasted by people on useless products in this area. However, it doesn’t mean that all supplements are useless. It’s not black and white. People should do their homework and also, look at the source of the food they are eating. Many of our soils are depleted of nutritional value and many studies show that people are not getting the recommended amount of important vitamins and minerals. (Also, provided there are no dangers, one cannot underestimate the placebo effect.)

Finally, the Australian Government would be much better putting the taxpayers money into setting up its own Choice type food laboratory and analysing the nutrient value of food grown and imported into Australia from a wide variety of sources and ESPECIALLY ANALYSING THE AMOUNT OF PESTICIDES and other contaminants in our food. I have heard that the funding for this has been seriously reduced over the last many years and, given the great deal of research showing a causal connection between pesticides and cancer, the Government should lift its game.

Thank you Prof Dwyer. My only prevarication on evidence-based medicine being that it highlights and directs people to studies that have proven to have no benefit, rather than the opposite, that because it hasn’t been studied yet it can’t be efficacious.

Certainly some Chinese and Indian medicinal practices are being supported by current research, with the benefits of turmeric for certain conditions being an example.

I look forward to the next instalments, and assume that the over-servicing of western medicine will feature somewhere. Recent studies suggest that the money wasted on over-servicing and over-prescribing might be as much, or more again, than all the quack medicines going, and just as dangerous.